FDA uses pharmacogenomics guidance in harmony with international definitions

WASHINGTON The Food and Drug Administration issued guidance on pharmacogenomic definitions and sample coding in order to bring it in line with that of Japan and the European Union.

The new guideline—“E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories”—provides information and definitions related to aspects covered by the definitions and related disciplines, such as proteomics and metabalomics.

The guidance defines a genomic biomarker as a “measurable DNA or RNA characteristic that is an indicator of normal biologic or pathogenic processes or a response to therapeutic or other interventions,” according to FDA reports. It also defines pharmacogenomics—the study of variations of DNA and RNA characteristics as related to drug response, and pharmacogenetics—the study of variations in DNA sequence as related to drug response.

The guideline also offers harmonized definitions for the four general coding categories of biological samples used to generate data in pharmacogenomic and pharmacogenetic studies.

The guidance is available at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0199-gdl.pdf.